Status:
COMPLETED
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Major Depressive Disorder With Mixed Features
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive d...
Eligibility Criteria
Inclusion
- Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
- Subject is 18 to 75 years of age, inclusive.
- Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version \[SCID-CT\]).
- Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):
- Elevated, expansive mood
- Inflated self-esteem or grandiosity
- More talkative than usual or pressure to keep talking
- Flight of ideas or subjective experience that thoughts are racing
- Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
- Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
- Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)
Exclusion
- Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
- Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
- Subject has attempted suicide within the past 3 months.
- Subject has a lifetime history of any bipolar I manic or mixed manic episode.
- Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT01421134
Start Date
September 1 2011
End Date
October 1 2014
Last Update
July 15 2016
Active Locations (43)
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1
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States, 35226
2
Synergy Clinical Research Center
Escondido, California, United States, 92025
3
Collaborative Neuroscience Network Inc.
Garden Grove, California, United States, 92845
4
Stanford -VA Palo Alto Health Care System
Palo Alto, California, United States, 94304